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510(k) Data Aggregation
K Number
K031818Device Name
FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE
Manufacturer
Date Cleared
2003-12-03
(174 days)
Product Code
Regulation Number
880.5580Why did this record match?
Applicant Name (Manufacturer) :
FACILAI ENTERPRISES LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is intended to pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
Device Description
FACILAI VARIOUS MODELS OF SINGLE USE ACUPUNCTURE NEEDLE
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